Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

Venatorx Pharmaceuticals, Inc.30 enrolled

Overview

This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

cefepime-taniborbactamDRUG

IV infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy adults 18-55 years 2. Males or non-pregnant, non-lactating females 3. Body mass index (BMI): ≥18 kg/m2 and ≤32.0 kg/m2, weight \>50.0 kg. 4. Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study Exclusion Criteria: 1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders 2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug 3. Recent history of known or suspected Clostridioides difficile infection 4. Abnormal ECG or history of clinically significant abnormal rhythm disorder 5. Abnormal lab tests

Locations (1)

Pulmonary Associates PA

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

ELF Cmax

Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF)

Time frame: 0-8 hours after 6th dose

Secondary Outcomes

Number of subjects with adverse events

Time frame: Day 1 - Day 8

Data from ClinicalTrials.gov

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